Completed FDA Clinical Trials

A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis during Vascular, Parenchymous, Soft Tissue, and Spinal Open Surgeries

The purpose of this clinical trial is to study the safety and efficacy of topical Thrombin (human) Grifols as an add-on treatment to help stop bleeding during vascular, parenchymous tissue (liver), soft tissue, and spinal open surgical procedures. Approximately 180 subjects will be treated with either topical Thrombin (human) Grifols (120 subjects) or Bovine Thrombin JMI® (60 subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by standard surgical techniques is ineffective or impractical and requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate the intensity of bleeding at the TBS. topical Thrombin (human) Grifols or Bovine Thrombin JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.Complete Listing

Outcome Measures

Primary Outcome Measures

Proportion of subjects achieving hemostasis at the TBS [Time Frame: 5 minutes following the start of treatment application]

The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.Complete Listing

Outcome Measures

Primary Outcome Measures
Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy.

Secondary Outcome Measures

Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma

Post-operative complications at original and re-operation

Peri-operative measures at original and re-operation

Survival

Arms

Assigned Interventions

Control:Traditional craniectomy

Procedure: Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.

Experimental: Craniectomy and dHACM placed over any dural defect or dural closure

Procedure: dHACM
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
Other Name: AmnioFix®

Eligibility

Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

Adults ages 18 or older.

Diagnosed with closed head trauma or cerebral infarction where decompressive craniectomy with durotomy is performed.

Willingness to comply with study procedures.

The patient’s or legally authorized representative’s (LAR’s) ability to give full written consent.

Exclusion Criteria

Prior surgery at the site

Participation in another ongoing trial

Open cranial wounds

Site exhibits clinical signs and symptoms of local infection.

Current diagnosis of cancer at the site

Prior radiation therapy treatment at the site.

Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.

Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

Presence of any condition(s) which seriously compromises the subject’s ability to complete this study, or has a known history of poor adherence with medical treatment.

Overall Success
A patient will be considered an overall success if all of the following conditions are met:

Pain/disability success;

No serious adverse events

For patients in the investigational group, no additional surgical procedure at the involved level classified as a failure. For patients in the control group, no “treatment surgery” at the involved level that was the result of a poor response to conservative care treatment.

Secondary Outcome Measures

Pain/Disability Status

Neurological Status

Pain Status (Back Pain and Leg Pain)

General Health Status

Interventions

Arms

Assigned Interventions

Experimental: Conservative care
Implantation of the DIAM Spinal Stabilization System

Device: DIAM™ Spinal Stabilization System
Surgical procedure with implantation of the Investigational device

Each patient participating in this clinical trial must meet all of the following inclusion criteria:

Has moderate low back pain secondary to lumbar degenerative disc disease at a single level from L2 – L5. Low back pain is defined as persistent back pain, with or without radicular pain, with current episode of less than one year duration. Degenerative disc disease is confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors (as measured radiographically by MRI scans or x-rays):

Decreased disc height >2mm, compared to the disc space at the next adjacent (superior or inferior, whichever has greater disc height) spinal level;

Has pre-treatment back pain score of = 8 based on the Pre-Treatment Back and Leg Pain Questionnaire (Back Pain Intensity + Back Pain Frequency).

Has been treated nonoperatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for a period of at least 6 weeks and not more than 6 months prior to enrollment in the clinical study.

If of child-bearing potential, patient is not pregnant or nursing and agrees not to become pregnant during the study period.

Is willing and able to participate in either of the randomized treatments for the duration of the study follow-up period. If the patient is randomized to the investigational group, he/she is willing to undergo surgery and receive the DIAM device. If the patient is randomized to the control group, he/she is willing to undergo all four nonoperative treatments.

Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria

A patient meeting any of the following criteria is to be excluded from this clinical trial:

Has disc height loss > 67% at the involved level, compared to the next adjacent (superior or inferior, whichever has greater disc height) spinal level

Has arachnoiditis.

Has a primary diagnosis of a spinal disorder other than degenerative disc disease at the involved level.

Requires treatment of degenerative disc disease at more than one lumbar level.

Has had all of the following nonoperative treatments (prescribed medications, active physical therapy, spinal injections, and patient education) within the past 6 weeks.

Has a sequestered herniated nucleus pulposus.

Has had any previous surgery at the involved or adjacent spinal levels (including procedures such as rhizotomy).

Has any disease (e.g., neuromuscular disease) that would preclude accurate clinical evaluation of the safety and effectiveness of the treatment regimens in this study.

Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment in the study.

Has an implantable metal device (e.g., stimulator, pacemaker) and is unable to have an MRI.

Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.

The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery. This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the EU and US.

If female and of child-bearing potential, subject has negative pregnancy test within 14 days prior to treatment and is not breast-feeding

If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

Mild to moderate surgical bleeding

Exclusion Criteria

Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors

Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)

Subject has known allergy to porcine gelatin

Subject is unwilling to receive blood products

Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)

Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease

Platelets < 100 x109 PLT/L during screening

DuraSeal Exact Spine Sealant System Post-Approval Study

This is a non-randomized, post-approval study to further evaluate the rate of post-operative cerebrospinal fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Device: DuraSeal Exact Spine Sealant System will be administered to the eligible patients to treat a dural opening.

Retrospective Control Arm: Subjects who have undergone a previous spinal procedure where Standard of Care is administered for the treatment of either an intentional or incidental opening of the dura

Control: Devices or drugs used to seal the dura

Eligibility

Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria (Prospective Treatment Arm)

Subject is 18 years of age or older

Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board.

Subjects that have a dural opening/tear will be treated with DuraSeal. However, in some instances, there may be an occasion where the investigator chooses not to use DuraSeal due to a specific surgical reason.

Exclusion Criteria (Prospective Treatment Arm)

The investigator determines that the subject will not be able to comply with the required follow-up visits

Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site’s standard of care is required)

Inclusion Criteria (Retrospective Control Arm)

Subject is 18 years of age or older

Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred

Informed consent has been provided by the subject (if required by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria (Retrospective Control Arm)

Subject has received DuraSeal Sealant (either cranial or spinal) during the target procedure

Pregnant or breastfeeding females (as documented in the medical records)

Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and a demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a “minimally manipulated” tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.

The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon’s choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.

Evaluation of Safety and Effectiveness of the OsseoFix® Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Alphatec Spine, Inc., is a medical device company that specializes in treating disorders that affect the aging spine. The company is conducting a clinical study with the OsseoFix® Spinal Fracture Reduction System which is for the treatment of vertebral compression fractures in the middle and lower back. The system provides internal fixation and stabilization using a permanent implant made of titanium and bone cement.Complete Listing

Some of the qualification criteria for study participation are the following:

50 years or older

Recently diagnosed with a vertebral compression fracture and conservative therapy (medication, bed rest, bracing, etc.) has failed for you

Diagnosed with Osteoporosis

Wallis® System – Clinical Trial for Lumbar Degenerative Disc Disease

Boulder Neurosurgical & Spine Associates (BNA) participates in this clinical trial to establish the safety and effectiveness of the Wallis® System. The study compares the Wallis dynamic stabilization system to total lumbar artificial disc replacement.

Participants in the trial are randomly selected to receive the Wallis device or a total lumbar disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine. The artificial disc is a FDA-approved, commercially-available implant designed to replace an entire diseased or damaged spinal disc through a surgery called “total disc replacement” (TDR). The Wallis System is designed to treat the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.Boulder Neurosurgical & Spine Associates (BNA) believes that by offering this clinical trial, it reinforces its commitment to give patients access to the latest investigational treatments for back pain.

Study objectives

The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is equivalent to total disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine at the L4 – L5 level.

Study overview

Approximately 25 medical centers are enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System in the treatment of mild to moderate degenerative disc disease.

The study is randomized so that 50 percent of the study participants will receive a Wallis device and 50 percent will receive a commercially available artificial disc (either the CHARITÉ® or PRODISC-L® artificial disc). Patients will be randomly assigned to receive either surgical option.

Study participants will receive all study-related tests and surgical procedures at no charge.

In contrast to traditional fusion surgery, in which two or more vertebrae are fused together, the Wallis device and lumbar artificial discs are motion-preservation technologies that allow the spine to continue to move. The Wallis device is placed between the spinous processes – ridges of the spine – and acts as a stabilizing spacer that may relieve symptoms of degenerative disc disease.

What does it mean to have a Total Disc Replacement?

Total Disc Replacement (TDR) is a surgical procedure in which a diseased or damaged disc is replaced with a mechanical device (artificial disc) that behaves similarly to the body’s natural disc. Artificial discs have been approved by the FDA for sale in the United States. Like many spinal implants, an artificial disc (TDR) is implanted using an anterior approach, which means the surgeon inserts the device through an incision made near your belly button. The primary advantage of receiving the TDR is that, unlike current fusion implants used to treat degenerative discs, the design of the TDR device allows the treated area of the spine to maintain movement.

The procedure may prevent adjacent level disc disease; a common problem associated with fusion surgeries.

What are the potential risks?

May not relieve all of the patient’s back pain, or could potentially make it worse.

The surgery is conducted through the abdomen rather than through the back. This can be more invasive.

May complicate the need for further surgical intervention, such as a fusion in the event that symptoms persist.

As with all surgeries, surgery-related complications may occur.

What is the Wallis device?

The Wallis device is a spinal implant that is surgically inserted between the bones in your back (called vertebrae). The device is designated to relieve low back pain caused by degeneration or damage to a disc in your spine. Disc degeneration can change the normal sagittal movements of and overall strength of the spine. Additionally, a degenerated disc may lose its ability to act as a shock absorber, which is important for day-to-day, pain-free living. These problems can progress to persistent low back pain.

The Wallis device attempts to restabilize or support the spine during the early stages of degeneration. It also aims to slow the breakdown of the disc while still allowing the spine to move normally.

Figure Legends: Plain X-rays (AP and lateral views with extension) taken three months after the surgery. A normal movement through L4-L5 could be observed). Unlike fusion surgeries, the Wallis device is designed to stabilize your spine without joining or “fusing” vertebrae.

The Wallis device is implanted using a posterior approach, which means it is inserted through a small incision in your back.

Has it been used before?

The Wallis device was originally developed in Bordeaux, France and has been in use in various parts of the world since 1986. Outside the US, more than 12,000 patients have been treated with the Wallis device. Up to this point, the FDA has not cleared Wallis for the use in the United States. The aim of the Wallis study is to gain approval for the use here.

Who is a good candidate for the study?

The Wallis study is intended for people with mild degenerative disc disease in the lumbar spine. The cost of the Wallis or disc replacement procedure will be covered by the study.

Patients must also meet the following criteria in order to take part in the Wallis study:

Age 18 – 60

Have experienced at least six months of failed non-surgical or “conservative care” treatments (physical therapy, medications, back injection, etc.)

Voluntarily read and sign the informed consent document

Who is not a good candidate for the study?

If one or more of the following apply, you will not be able to take part in the study:

Disc problems at other than the L4-L5 levels

Leg pain greater than back pain

Unwilling to undergo surgery

Bacterial infection

Poor bone quality

HIV or Hepatitis

Lumbar Stenosis

Pregnant

Uncontrolled Diabetes

Extreme obesity

Prior participation in a clinical study of any investigational spinal implant or spinal treatment

Previous fusion at the same or adjacent levels being studied

What are potential benefits?

May relieve pain without requiring spinal fusion.

Surgery is relatively conservative when compared to other surgical choices, like fusion or disc replacement.

The Wallis procedure does not prevent the need for another procedure (e.g., fusion or disc replacement) if problems persist.

What are potential risks?

May not relieve all of the patient’s back pain, or could potentially make it worse.

The Advent™ Cervical Disc Clinical Trial

BNA participates in a clinical trial for a new investigational device, namely the Advent™ Cervical Disc. The Advent™ Cervical Disc is one of the first cervical artificial discs for the treatment of one level degenerative disc disease to incorporate a flexible elastomer core, which is designed to provide advanced biomechanical properties.

The purpose of the research study is to evaluate the safety and effectiveness of the Advent™ Cervical Disc in patients who have neck problems and that require surgery to replace the disc found between the cervical vertebrae following discectomy. Patients that have failed conservative treatment for at least six weeks for nerve root and/or spinal cord compression due a herniated disc and/or osteophyte formation between C3 and C7 may be eligible for enrollment in the study. Enrollment eligibility will be confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, X-rays, etc.).

Caution: Investigational Device – Limited by Federal Law to Investigational Use

MAVERICK™ – FDA Lumbar Artificial Disc Study

The MAVERICK™ artificial disc is a spinal arthroplasty system intended for use in the lumbar spine to treat degenerative disc disease. The device is a permanent implant that is intended to maintain motion at the treated level. While a fusion remains the standard of care, the artificial disc may provide an alternative solution for those patients suffering from degenerative disc disease.

A multicenter clinical study was initiated in the United States in the spring of 2003 and was completed in 2012. The clinical trial data will be submitted for approval by the US Food and Drug Administration (FDA) to commercialize the implant.

The purpose of this clinical trial is to evaluate the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4 to S1. Patients who enroll in the clinical study are randomly assigned a treatment group. Approximately two-thirds of the patients receive the MAVERICK™ Artificial Disc and one-third of the patients receive the lumbar fusion.

A Study Evaluating the Efficacy and Safety of Fibrin Sealant for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

The purpose of this research is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.

In order to perform the brain surgery, the surgeon will cut through the skull (a procedure is known as a craniotomy) and through the dura (one of the tissue layers covering the brain). The space between the dura and the brain is filled with cerebral spinal fluid called CSF. The use of a sealant on top of the sutures used to close the opening in the dura may help control CSF leakage after the surgery. The product to be studied, Fibrin Sealant, Vapor Heated, Solvent/Detergent 500 s-apr (FS VH S/D 500 s-apr), is a fibrin sealant known as a surgical “glue” made out of two substances naturally found in the human body, thrombin and fibrinogen. When mixed together, they help to form a clot. The human body naturally absorbs the clot over a period of about 14 days.

This study will also look at how often infection occurs, if there are any side effects from the sealant, and what are the procedures required to treat CSF leakage after surgery. FS VH S/D 500 s-apr is investigational and is not approved by the U.S. Food and Drug Administration (FDA) for sealing dura sutures in the USA.

BNA has been selected to participate in a landmark international clinical trial for cancer patients who have experienced a fracture of the spine known as a vertebral compression fracture (VCF). Many cancer patients, especially those suffering with multiple myeloma, experience such fractures of the spine, which can cause debilitating back pain and substantially reduce their quality of life.

The Cancer Patient Fracture Evaluation (CAFE) study is designed to compare the safety and effectiveness of two alternative treatments for painful, acute VCFs: a surgical treatment known as Balloon Kyphoplasty and non-surgical treatment. Balloon Kyphoplasty is a minimally invasive spine procedure that has been shown in non-randomized clinical trials to relieve pain, improve function and quality of life, restore vertebral height and correct spinal deformity. To date over 210,000 patients worldwide have had VCFs treated with Balloon Kyphoplasty. Traditional non-surgical treatments for spinal fractures in cancer patients include bed rest, medication, back bracing, walking aids, radiation, and physical therapy.The US Food and Drug Administration (FDA) has already cleared devices for use in Balloon Kyphoplasty for the treatment of VCFs in cancer patients. The purpose of this postapproval, randomized, controlled clinical trial is to collect further evidence that may support the Balloon Kyphoplasty treatment option. The study will evaluate a total of 200 patients at up to 30 centers across the United States, Canada, Europe and Australia.BNA has joined the CAFE trial as part of its dedication to improving the quality of life for people with cancer. Dr. Alan Villavicencio is one of the first to bring this new treatment option for cancer patients in Colorado and will be performing the Balloon Kyphoplasty procedures

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